Seizure Prophylaxis in Aneurysm Repair

Phase 4

Completed

• Conditions: Intracranial Aneurysms; Seizure
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01801072
• Lead Sponsor: University of Michigan

Brief Summary

After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Results First Submitted: 2024-09-30
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Results First Posted: 2024-11-28
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Adult (≥18 years)
• Presence of intracranial aneurysm (with or without rupture)
• Treating surgeon has recommended surgical repair of the aneurysm

Exclusion Criteria

• History of seizures within last 10 years
• History of epilepsy
• History of prior stroke
• Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.)
• Brain tumor
• Pregnant or nursing woman
• Known levetiracetam allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.

Primary Outcome Measures

Name	Time	Method
Incidence of Seizure	5 years from procedure	Incidence of seizure reported as number of participants who had at least one seizure within the relevant date range. Data collected at hospital discharge, 1-2 months, 4-6 months, 6-12 months, and 5 years. Data is not cumulative. Counts reflect the number of participants who experienced a seizure since their previous check-in.

Secondary Outcome Measures

Name	Time	Method
Duration of Seizure	To compare duration of seizure in each randomization group	Duration of seizure

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States